a randomised double blinded observational study for comparison of intermittent boluses of nor-epinephrine and phenylephrine for prevention of subarachnoid block induced hypotension in cesarean section

comparison of intermittent boluses of nor-epinephrine and phenylephrine for prevention of subarachnoid block induced hypotension in cesarean section

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/03/012839

Enrollment

200

Registered

2018-03-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Pregnant Females

Interventions

Intervention1: nor-epinephrine: potent alpha-adrenergic agonist action alongwith mild beta-adrenergic effect and, hence does not reduce heart rate (HR) and cardiac output (CO).Study bolus of 4 micro

Eligibility

Inclusion criteria

Inclusion criteria: 1)American society of Anesthesiologists (ASA) physical status II undergoing lower segment cesarean section (LSCS) under subarachnoid block (SAB). 2)Primigravida. 3)Healthy singleton pregnancy. 4)Age more than 18 years. 5)Weight 50-100 kg. 6)Height 150-180 cm.

Exclusion criteria

Exclusion criteria: 1)Onset of labour. 2)Known fetal abnormality. 3)Severe cardiovascular or cerebrovascular disease or renal impairment. 4)Known allergy to any study medication. 5)Patients taking monoamine oxidase or tricyclic antidepressants. 6)Presence of mesenteric or peripheral vascular thrombosis.

Design outcomes

Primary

Measure	Time frame
Comparative success of intermittent boluses of nor-epinephrine and phenylephrine to maintain systolic blood pressure (SBP) at 90-100% of baseline, from induction of spinal anesthesia to delivery of fetus.Timepoint: From induction of spinal anesthesia to delivery of fetus	—

Secondary

Measure	Time frame
.Total amount of boluses of Nor- epinephrine/Phenylephrine used till the time of delivery. .Episodes of hypertension. .Incidence of bradycardia. .Number and timing of episodes of hypotension shall also be recorded. .Incidence of intraoperative nausea, vomiting (IONV). .APGAR score at 1 minute and 5 minutes. Timepoint: The time points of -spinal anesthesia administration -surgical incision -delivery of baby -technical problems during surgery, if any	—

Measure

Time frame

.Total amount of boluses of Nor- epinephrine/Phenylephrine used till the time of delivery. .Episodes of hypertension. .Incidence of bradycardia. .Number and timing of episodes of hypotension shall also be recorded. .Incidence of intraoperative nausea, vomiting (IONV). .APGAR score at 1 minute and 5 minutes. Timepoint: The time points of -spinal anesthesia administration -surgical incision -delivery of baby -technical problems during surgery, if any

—

Countries

India

Contacts

Public ContactDr Anju Grewal

Dayanand Medical College & Hospital

dranjugrewal@gmail.com9815482626

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026